Effect of Pre-emptive Assessment of Self-care Peritoneal Dialysis (PD) Ability on PD Choice in Patients With Stage 5 Chronic Kidney Disease

NCT04967547 | Unknown

• 1 other identifier: self-care PD ability
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

Peritoneal dialysis is an effective renal replacement therapy with higher quality of life and lower treatment cost than hemodialysis.However, the application rate of peritoneal dialysis is much lower than that of hemodialysis. One of the reasons is that patients need to complete fluid changing operation independently, which is especially challenging for elderly and frail patients. Assisted peritoneal dialysis can help patients with independent dialysis disorders to complete dialysis. Currently, there is a lack of standard tools to assess patients' ability to conduct independent dialysis and to determine whether assisted dialysis is needed. Moreover, routine assessment is arranged after the training of dialysis operation, which leads to some patients giving up the procedure at an early stage, resulting in a low selection rate of the procedure.The purpose of this study was to investigate the effect of using a standard scale to evaluate the ability to perform abdominal dialysis in patients with stage 5 chronic kidney disease (CKD) before deciding on dialysis modality.

Conditions

Chronic Kidney Disease (CKD) Stage 5

Outcome Measures

Primary Outcomes (1)

• The rate of PD choice

  up to 90 days

Secondary Outcomes (1)

• The aPD utilization rate

  up to 180 days

Study Arms (2)

Intervention group

EXPERIMENTAL

be evaluated by using the self-care PD feasibility assessment in addition to education on renal replacement therapy and dialysis

Other: Self-care PD ability assessment form; Other: Education

Control group

ACTIVE COMPARATOR

education on renal replacement therapy and dialysis

Other: Education

Interventions

Self-care PD ability assessment form OTHER

Subjects will be evaluated using the self-care PD feasibility assessment tool within 7 days after randomization. The evaluation results will be provided to the patient on the same day

Intervention group

Education OTHER

Education on renal replacement therapy and dialysis

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 years old;
• Need dialysis within 6 months;
• Informed consent.

You may not qualify if:

• Absolute PD contraindications;
• Need urgent dialysis;
• RTX as initial renal replacement therapy.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Wei Fang, MD

  RenJi Hospital

  STUDY DIRECTOR

Central Study Contacts

Na Jiang, MD

CONTACT

+86-21-53882014; Jiangjiang198311@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Nephrology

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 19, 2021

Record last verified: 2021-07

Locations

CN (1)